NCT07545902Recruiting
Clinical Study on the Medical Devices PROXERA PSOMED 20 and PROXERA PSOMED 40 for the Treatment of Plaque Psoriasis and Non-pustular Palmoplantar Psoriasis
Evaluation of the Efficacy and Safety of the Medical Device PROXERA PSOMED 20 in Reducing Psoriatic Plaques and of the Medical Device PROXERA PSOMED 40 in Reducing Non-pustulous Palmoplantar Psoriasis Flaw in Patients With Plaque Psoriasis: a Sponsored, Interventional, Single-center, Randomized, Single-blind, Intra-patient Controlled Study (PASI)
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
This single-center interventional study was designed to evaluate the efficacy and safety of two CE-marked topical medical devices: PROXERA PSOMED 20 is being studied in participants with non-palmoplantar plaque psoriasis, while PROXERA PSOMED 40 is being studied in participants with non-pustular palmoplantar psoriasis. The study aims to determine whether treating a target area with the assigned medical device leads to greater clinical improvement compared to the untreated contralateral control area in the same participant. For PROXERA PSOMED 20, the primary assessment is performed after 4 weeks of treatment. For PROXERA PSOMED 40, the primary assessment is performed after 8 weeks of treatment. Secondary objectives include the assessment of safety, local tolerability, overall psoriasis progress, its impact on quality of life, and additional parameters of local disease activity at the target areas. Participants will apply the assigned study device once daily to the selected target area, undergo clinical assessments at scheduled visits, and provide safety and tolerability information throughout the study.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 30 Apr 2026
- Primary completion date
- 25 Nov 2026
- Lead sponsor
- ICIM International S.r.l.
- Diseases
- Psoriasis
- NCT number
- NCT07545902
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 30 Apr 2026 to the primary completion date, 25 Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant therapy with systemic immunomodulatory drugs (e.g., methotrexate, cyclosporine, apremilast)
- Concomitant therapy with biologic drugs such as anti-TNFα, anti-IL17, or anti-IL23.
- Concomitant topical therapy with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), vitamin D analogues, and combinations.
Other
- Product intolerance
- Pregnant or breastfeeding women
Who the study is looking for
- PROXERA PSOMED 20 - normalizing cream, 20% urea
- Diagnosis of plaque psoriasis (not palmoplantar) for at least 1 year PROXERA PSOMED 40 - intensive exfoliating gel, 40% urea
- Diagnosis of non-pustular palmoplantar psoriasis for at least 1 year
- Common inclusion criteria:
- Age 18-65 years
- "Mild" psoriasis severity according to:
- Psoriasis Area Severity Index (PASI) \<10
- Dermatologic Life Quality Index (DLQI) \<10
- Body Surface Area (BSA) \<10
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinica Dermatologica Dipartimento di Medicina e Scienze dell'Invecchiamento Università G. D' Annunzio Coordinator of this site? Confirm its status | Chieti | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.